Current Trends in Bariatric Surgery

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1 Current Trends in Bariatric Surgery Abraham Krikhely, MD, FACS, FASMBS Assistant Professor of Surgery, CUMC Center of Minimal Access, Metabolic and Weight Loss Surgery

2 Outline Why consider surgery Bariatric surgery as metabolic surgery Considering surgery at lower BMIs Change in the types of cases being performed Emergence of robotic bariatric surgery

3 Why consider surgery?

4 Surgery shown to improve survival Sjostrom et al. Effects of Bariatric Surgery on Mortality in Swedish Obese Subjects. (NEJM, 2007) Prospective cohort study SOS Study 4047 pts. o 2010 patients in surgery group (68% VBG, 19% Band, 13% GBP) 10.9Y avg. f/u weight loss 25% GBP, 16% VBG, 14% Band Overall mortality reduced 24% in surgery group 40% fewer cancer deaths, 50% fewer MI deaths

5 Surgery shown to improve survival Adams et al. Long-Term Mortality after Gastric Bypass Surgery. (NEJM, 2007) 7925 GBP and 7925 Matched Controls o Age, sex, BMI from DMV records, year All cause and disease specific mortality o Avg. f/u 7.1Y Overall Mortality 40% less in GBP group o 59% fewer deaths due to MI, 92% fewer due to diabetes, and 60% to cancer

6 Remission of comorbid conditions Remission Improvement SG GB SG GB SG GB SG GB SG GB SG GB SG GB SG GB Hypertension Dyslipidemia Diabetes OSA Back/joint pain GERD Hyperuricemia Depression 1. Peterli et al. Laparoscopic sleeve gastrectomy versus roux-y-gastric bypass for morbid obesity 3-year outcomes of the prospective randomized Swiss multicenter bypass or sleeve study (SM-BOSS). (Ann Surg, 2017)

7 Bariatric surgery increasingly seen as metabolic surgery The GI tract is more than just plumbing. The alterations in anatomy lead to hormonal changes in the gut-brain hormonal axis that lead to weight loss and changes in glucose homeostasis

8 45 medical societies support surgery to treat diabetes Diabetes Surgery Summit II (2015) Recommend metabolic surgery to treat T2DM BMI > 40 and BMI hyperglycemia inadequately controlled. Consider for patients with T2DM and BMI if inadequately controlled despite optimal medical treatment with either oral meds or injectables Endorsed by 45 worldwide medical and surgical societies 1. Rubino et al. Metabolic surgery in the treatment algorithm for type 2 diabetes: a joint statement by International Diabetes Organizations (SOARD, 2016)

9 Multiple RCTs have shown effectiveness of surgery No mortalities major complication rates < 5% Surgery effective against diabetes and reduced medications taken, weight, and dyslipidemia 1. Schauer et al. Clinical outcomes of metabolic surgery: Efficacy of glycemic control, weight loss, and remission of diabetes (Diabetes Care, 2016)

10 Ikramuddin et al. Roux-en-Y gastric bypass for diabetes (the Diabetes Surgery Study): 2-year outcomes of a 5-year, randomized, controlled trial. (Lancet, 2015) Randomized groups: intensive medical therapy (n=60) vs RYGB + intensive medical therapy (n=60) Inclusion: A1C > 8%, BMI , T2DM for >6 months avg BMI 34, avg A1C 9.6% Primary endpoint: Triple control - A1C < 7%, LDL < 2.59 mmol/l, SBP < 130mmHg 24 months: Meeting triple control endpoint: RYGB+IMT 43% vs IMT 14% A1C < 7: RYGB+IMT 75% vs IMT 24% Gastric bypass group had a greater number of adverse events including falls, fractures, infections and nutritional deficiencies despite use of nutritional supplements

11 Mingrone et al. Bariatric Surgery versus Conventional Medical Therapy for Type 2 Diabetes RCT RYGB vs BPD vs MT (lifestyle, exercise, nutrition) n= 60 (inclusion: BMI > 35, A1C > 7, DM > 5 years) Primary endpoint: HbA1C < fasting glucose < 5.6, without meds x1 year EWL 2 yrs 5 yrs RYGB 68% 67% BPD 69% 73% Medical 9% 16% DM remission Patients who relapsed diabetes at 5 years able to maintain A1C 6.7% with diet +- metformin alone 2yrs 5yrs 75% 37% 95% 63% 0% 0% 1. Mingrone et al. Bariatric Surgery versus Conventional Medical Therapy for Type 2 Diabetes. (NEJM, 2012) 2. Mingrone et al. Bariatric-metabolic surgery versus conventional medical treatment in obese patients with type II diabetes: five-year follow-up of an open-label, single-center, randomized controlled trial. (Lancet, 2015)

12 Schauer et al. Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes RCT RYGB vs SG vs MT (lifestyle, exercise, nutrition) n = 150 (avg preop A1C 9.3, BMI 36) Primary endpoint: A1C < 6% +- DM medications %EWL 3 yrs 5 yrs RYGB 73% 68% SG 72% 61% Medical 14% 8% Primary endopoint 3yrs 5yrs 38% 29% 24% 23% 5% 5% HgA1C base 5yrs Schauer et al. Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes. (NEJM, 2012) 2. Schauer et al. Bariatric surgery versus intensive medical therapy for diabetes - five-year outcomes. (NEJM, 2017)

13 Who Qualifies? BMI > 40 BMI > 35 with comorbidity Medically fit and optimized to undergo surgery No psychiatric contraindications Needs to be able to understand and be committed to behavior changes necessary to ensure safety and success No strict age limits (adolescents and elderly have special considerations)

14 Should surgery be considered at lower BMIs? Most insurances currently still require BMI > 35 for diabetics to qualify for surgery Data suggests that BMI is not a good predictor of effectiveness of surgery Recent meta-analysis showed no difference in remission of diabetes if BMI < 35 vs BMI > 35 (Panunzi, 2015) Strong support of DSS-II consensus statement aiming to get change in insurance policies for lower BMI 1. Panunzi et al. Predictors of remission of diabetes mellitus in severely obese individuals undergoing bariatric surgery: do BMI or procedure choice matter? A meta-analysis (Ann Surg, 2015) 2. Rubino et al. Metabolic surgery in the treatment algorithm for type 2 diabetes: a joint statement by International Diabetes Organizations (SOARD, 2016)

15 How safe is it?

16 Minimally Invasive Bariatric Surgery is Safe (JACS, 2015) Analysis of ACS NSQIP database 24,117 patients (20% SG, 80% GB)

17 (Young et al, JACS 2015)

18

19 Robotic Bariatric Surgery

20 Pros and Cons Pros great visualization (high resolution, 3D, stable camera position, great magnification) more stable retraction more dexterity and precision increased autonomy better ergonomics for the surgeon Stapler can assess thickness of the tissue increased cost Cons increased OR time learning curve (both surgeon and staff) can t feel the tissue (haptics) less global experience with the robotic stapler and instruments relative to the lap equivalents is the technology reliable? potential of future development on the platform

21 Utilization and outcome of laparoscopic versus robotic general and bariatric surgical procedures at Academic Medical Centers Nguyen N, Surg Endosc (2015) HealthSystem Consortium clinical database from 10/2010 to 2/2014 Shorter LOS for heller myotomy Costs were significantly higher for all procedures For SG and GB - no increase in hospital mortality, major complications and 30-day readmissions with robotic surgery Robotic versus laparoscopic sleeve gastrectomy for morbid obesity: systematic review and meta-analysis Magouliotis (Obes Surg, 2017) Included 16 studies and 29,787 patients Majority of studies found increased costs and OR times associated with robotic sleeve gastrectomy No differences in rates of leaks or bleeding

22 Laparoscopic versus robotic roux-en-y gastric bypass: lessons and long-term follow-up learned from a large prospective monocentric study. Buchs et al. (Obesity Surgery, 2014) lap GB, 388 robotic GB robotic bypass had lower conversion rate (0.8% vs 4.9%), fewer complications (11% v 16%), fewer leaks (0.3% v 3.6%), shorter hospital stay handsewn GJ for robotic, circular stapled GJ for lap

23 Current studies are limited Are early studies just capturing the results and costs of the learning curve? Older generation robot Unclear on technique used during the surgery Lack of uniformity on technique

24 Future for robotic bariatric surgery Once people get over the learning curve, will we see an improvement in outcomes, OR efficiency, and costs? Will better visualization and precision translate into better results? Increased competition (Google/J&J, medtronic, others)over next few years Decreased costs Innovations in technology (single-site, embedded imaging, haptics) Decreased size of the platform system to become more mobile

25 Summary Metabolic surgery is the most effective treatment currently available for morbid obesity and diabetes Minimally invasive bariatric surgery is safe Push towards offering metabolic surgery to lower BMIs Mix of cases continues to evolve May see an increased role for robotics with greater surgeon experience, increased industry competition and lower cost.

26 Thank you Abraham Krikhely, MD, FACS, FASMBS

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